MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTERLINK BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303345
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported that the tips of the cannula are breaking off into a vial or prior to injection.As a sample was unavailable for return, a thorough sample investigation could not be completed.It could be possible the customer is not using the product as intended.This product is not designed to be inserted through the stopper vial.If the product is not meeting the customer¿s needs, it may be beneficial to contact the local bd sales, or marketing representative, for additional product options.A device history record review was completed for provided material number 303345, lot number 1096755.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 3 bd interlink¿ blunt plastic cannulas' tips broke off: 2 into the vials when drawing up medicine, and 1 while opening the cannula.The following information was provided by the initial reporter: "customer reported they used this cannula and some of the tips of the cannulas are breaking off into the vials when they are drawing them up.Two occurrences happened when drawing up from a vial the tip broke off in the vial and 1 occurrence was when opening the cannula tip broke instantly.".

• Brand Name: BD INTERLINK BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12468565
• Report Number: 1911916-2021-00985
• Device Sequence Number: 17366321
• Product Code: FMI
• UDI-Device Identifier: 30382903033455
• UDI-Public: 30382903033455
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2026
• Device Model Number: 303345
• Device Catalogue Number: 303345
• Device Lot Number: 1096755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1